BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM

    MDR report key: 3223424 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04175
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SINGLE SCREW THAT IS STILL PARTIALLY INSERTED INSIDE A REAMER TUBE FOR A HOLLOW REAMER WAS RECEIVED WITH THE SUBTASK ASSOCIATED WITH THIS COMPLAINT. THE SCREW THREAD DIAMETER IS 4.96MM. THERE ARE THREE FLUTES AND THE SHAFT HAS BEEN ANODIZED GREEN. APPROXIMATELY 11 THREADS BEGINNING AT 20MM FROM THE TIP HAVE BEEN COMPRESSED AT THE MAJOR DIAMETER. THERE ARE ALSO MULTIPLE IMPACT / COMPRESSION MARKS AT THE MAJOR DIAMETER THAT APPEAR TO HAVE BEEN MADE BY A GRIPPER DEVICE, WHICH WOULD BE CONSISTENT WITH AN EXTRACTION. THERE APPEARS TO BE BIO-MATERIAL ON THE THREADS OF THE SCREW THAT CAN BE SEEN THROUGH THE OPENINGS OF THE REAMER. THE REMAINDER OF THE THREADS ARE IN GOOD CONDITION, AS ARE THE FLUTES AND TIP. THE THREADS ARE OF THE TYPE FOUND ON COMBI SCREWS, BUT THE FLUTES DO NOT MATCH ANYTHING PRODUCED IN MONUMENT. THESE FLUTES APPEAR TO BE OF THE TYPE MANUFACTURED AT THE EU FACILITIES. WITHOUT BEING ABLE TO SEE THE DRIVE, WE CANNOT POSITIVELY IDENTIFY THIS SCREW. BECAUSE OF THE TYPE AND EXTENT OF DAMAGE INCURRED, AND ALSO BECAUSE NO PART NOR LOT NUMBERS WERE PROVIDED, NO FINITE EVALUATION CAN BE PERFORMED. THEREFORE, THIS COMPLAINT IS JUDGED TO BE INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED (B)(6) 2011. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFO: ADDITIONAL PRODUCT CODE: KTT. ADDITIONAL NARRATIVE: BASED ON THE COMPLAINT DESCRIPTION, THE SURGEON FOUND IT NECESSARY TO CUT OFF THE HEAD OF THE SCREW IN ORDER TO EXPLANT THE HARDWARE ORIGINALLY IMPLANTED (B)(6) 2011. THE ISSUE NOTED FOR THE SCREW WAS THAT THE HEAD OF THE SCREW WAS STRIPPED. SINCE THE HEAD OF THE SCREW WAS CUT-OFF AND NOT RETURNED, NO EVALUATION OF THE SCREW RECESS WAS POSSIBLE BUT THE CAUSE OF STRIPPING WAS MOST LIKELY THE RESULT OF EXCESSIVE FORCE EXERTED ON THE SCREWDRIVER DURING EXTRACTION. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THEREFORE, THIS IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    CONSULTANT REPORTS THAT DURING A PROCEDURE TO REMOVE A DISTAL FEMUR PLATE, TWO SCREW HEADS WERE STRIPPED. THE SURGEON HAD TO CUT OFF THE HEADS OF THE SCREWS IN ORDER TO REMOVE THE HARDWARE. THIS RESULTED IN A ONE HOUR DELAY TO THE PROCEDURE. THE HARDWARE WAS IMPLANTED IN (B)(6) 2011 TO CORRECT A DISTAL FEMUR DEFORMITY. THIS WAS A SCHEDULED PROCEDURE FOR REMOVAL OF HARDWARE FOLLOWING SUCCESSFUL HEALING OF THE PATIENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4) AND IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323003 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention